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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
existing study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Apri1 9 -16, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study similar to the OECD guideline under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Identity: Alkylnaphthalene sulfonic acid
- Physical state: Dark brown viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst. MA
- Age at study initiation: young adult
- Weight at study initiation: not indicated
- Housing: individually
- Diet: Pelleted Purina Rabbit Chow #5326, ad libitum
- Water: Filtered tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 7 days after patch removal
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 4-p1y gauze pad wrapped with 3 inch Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 4-p1y gauze pad wrapped with 3 inch Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of residual test substance with mineral oil, acetone and water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.6
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
not irritant, no signs of corrosion
Other effects:
no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior

Any other information on results incl. tables

Animal no

1

2

3

Day

1

24

48

72

7

1

24

48

72

7

1

24

48

72

7

erythema

2

2

1

1

0

2

2

2

1

0

2

2

2

2

0

oedema

0

0

0

0

0

0

0

0

0

0

1

1

1

1

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not irritating to the skin.
Executive summary:

The test substance was applied on the skin of 3 rabbits. No signs of irritation were observed during the 7 day observation period. According to the CLP criteria the test substance is not considered to be irritant to the skin.